Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06499116

Comparison of the Effectiveness of First-line Preventive Treatment of Migraine in Primary Care

This study, which is aimed at comparing the effectiveness of the most frequently used drugs in the first line in primary care for the preventive treatment of migraine (amitriptyline, flunarizine, topiramate and propranolol), is a multicentre, pragmatic, parallel group, open randomised trial. Adults (≥18) candidates for preventive treatment for migraine; those with a frequency of ≥4 monthly migraine days, and who agree to participate in the clinical trial, will be randomised to one of the 4 groups. Sample: 460 patients. The primary outcome will be the reduction in monthly migraine days, comparing amitriptyline, flunarizine and topiramate with propranolol.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults (≥18) candidates for preventive treatment for migraine; those with a frequency of ≥4 monthly migraine days, and who agree to participate in the clinical trial.

Exclusion criteria

  • People diagnosed with migraine who are not candidates for preventive migraine treatment
  • People diagnosed with chronic migraine (>15 days of headache per month, of which 8 are monthly migraine days)
  • Not having a smartphone
  • Simultaneous participation in another clinical trial
  • Pregnancy or expected pregnancy during the next 3 months
  • Lactation
  • People with migraine who already receive preventive treatment.
  • People on chronic treatment with opioids or other analgesics or NSAIDs that are not used for the symptomatic treatment of migraine, for example, osteoarthritis.
  • People who, in the opinion of the clinician, have an absolute contraindication to one of the study drugs or who cannot perform the trial procedures:

Hypersensitivity to any of the study drugs / Heart block or severe bradycardia / Concomitant treatment with verapamil or diltiazem / Active cardiovascular pathology (recent heart attack, angina, Raynaud's phenomenon) / Major depression or active treatment with antidepressants (including monoamine oxidase inhibitors and St. John's wort) / Other psychiatric illnesses or active treatment with antipsychotics or lithium / Severe liver disease or kidney failure / Parkinson's disease or other extrapyramidal disorders / Epilepsy (diagnosis and/or active treatment) / Any other contraindication that, in the opinion of the clinician, prevents participation in the clinical trial

Treatment and study plan

Topiramate

Drug

Treatment will be prescribed for GPs and they will decide the specific dosage 25-100 mg/12h.

Other names: Acomicil

flunarizine

Drug

Treatment will be prescribed for GPs and they will decide the specific dosage 2,5-10 mg mg/24h.

Other names: Sibelium

Amitriptyline

Drug

Treatment will be prescribed for GPs and they will decide the specific dosage 10-75 mg/24h.

Other names: Tryptizol

Propranolol

Drug

Treatment will be prescribed for GPs and they will decide the specific dosage 20-120 mg/12h.

Other names: Sumial

Primary outcomes

  1. To evaluate the effectiveness of the most frequently used drugs in primary care for the preventive treatment of migraine according to the reduction in monthly migraine days, comparing amitriptyline, flunarizine and topiramate with propranolol.

    Time frame: 12 weeks

    Clinical effectiveness: change in the mean number of monthly migraine days (MMD) at 12 weeks of treatment from baseline.

Secondary outcomes

  1. Calculate the rate of responders (reduction of at least 50% in monthly migraine days compared to baseline)

    Time frame: 12 weeks

    Proportion of patients responding at 12 weeks from start of treatment; <25% change in mean number of MMD: non-responders, 25-49%: partial responders, 50-75%: responders, >75%: excellent responders.

  2. Evaluate effectiveness before completing the clinical trial

    Time frame: 4, 8 and 12 weeks

    Change in mean number of MMDs at 4 and 8 weeks from baseline.

  3. Estimate the reduction in the intensity of migraine attacks

    Time frame: 4, 8 and 12 weeks

    Reduction in the mean number of moderate-severe MMD at 4, 8 and 12 weeks from the start of treatment.

  4. Estimate the prevalence of symptoms associated with migraine

    Time frame: 12 weeks

    Proportion of patients with associated symptoms at 12 weeks from the start of treatment; photophobia, phonophobia, nausea.

  5. Evaluate adherence to preventive treatment

    Time frame: 12 weeks

    Proportion of adherent and non-adherent patients (according to taking [yes/no] of the study treatment with the prescribed dosage) at 12 weeks from the start of treatment.

  6. Estimate the reduction in the use of symptomatic treatment drugs used to treat migraine attacks (analgesics, NSAIDs, triptans, others).

    Time frame: 4, 8 and 12 weeks

    Change in the mean number of drugs used for symptomatic treatment at 4, 8 and 12 weeks from baseline.

  7. Evaluate reconsultation visits due to migraine attacks

    Time frame: 4, 8 and 12 weeks

    Reconsultations: Type of consultation (PCC, PC emergency, hospital, hospital emergency). Number of consultations after 12 weeks from the start. Number of medical tests performed relacionadas con la migraña.

  8. Evaluate improvement in quality of life and patient satisfaction

    Time frame: 12 weeks

    Change in EQ-5D-5L questionnaire at 12 weeks from baseline. Including Visual Analogue Scale (0-100). Lower scores means worse health condition.

  9. Analyze the differences between men and women regarding study drugs effectiveness.

    Time frame: 4, 8 and 12 weeks

    Result comparison change in mean number of MMDs adjusted by sex

  10. Estimate the disability associated with migraine attacks according to number of paticipans reporting temporary work disability, absenteeism, presenteeism.

    Time frame: 12 weeks

    Change in the number of ILT days, absenteeism, presenteeism at 12 weeks from the start of treatment.

  11. Incidence of adverse events of the four drugs used in the preventive treatment of migraine .

    Time frame: 12 weeks

    Number of adverse events

Study contacts

Contact information is provided by the study sponsor or research team.

Ana Garcia-Sangenis

CONTACT

[email protected]

+34 93 482 4651

Maria Giner-Soriano

CONTACT

[email protected]

+34 93 482 4110

Sponsors and collaborators

Lead sponsor

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Other

Collaborators

  • Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
  • Institut Català de la Salut

Registry information

Official study title

Comparison of the Effectiveness of First-line Preventive Treatment of Migraine in Primary Care: a Pragmatic Clinical Trial [PREMI Study]

Acronym: PREMI

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 12, 2024
Registry last updated
Jul 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.